Services

Ten disciplines. One integrated perspective.

Support across science, compliance, evidence and execution—delivered nationwide for clinical laboratories, molecular diagnostics developers, biotechnology and healthcare organizations.

Schedule a Consultation

Molecular Assay Development & Optimization

Assay feasibility, panel design support, multiplex real-time PCR and NGS workflows, troubleshooting, assay transfer and version bridging.

Typical deliverables: Assay development plans; Technical protocols; Optimization reports; Feasibility and gap assessments.

Explore service

Analytical Validation & Method Verification

Validation strategy and study design for accuracy, precision, LoD, inclusivity/exclusivity, interference, carryover, stability and comparability.

Typical deliverables: Validation plans; Protocols; Data review; Statistical summaries; Final analytical validation reports.

Explore service

Clinical Validation & Evidence Strategy

Comparator study design, specimen sourcing, target-level PPA/NPA with confidence intervals, discordance investigation and claim alignment.

Typical deliverables: Clinical validation protocols; Comparator analyses; Evidence matrices; Technical narratives.

Explore service

Regulatory & Laboratory Compliance Support

CLIA/CAP-oriented gap assessments, inspection preparation, quality management systems, SOPs, competency programs and FDA submission planning.

Typical deliverables: Gap assessments; SOP suites; Inspection-readiness plans; Submission-support documentation.

Explore service

MolDx, DEX Z-Codes & Technical Assessment

MolDx technical assessment readiness, coverage-policy mapping, evidence gap analysis, response packages and DEX Z-Code support.

Typical deliverables: Technical assessment responses; Remediation roadmaps; Submission checklists; Supporting exhibits.

Explore service

CPT / PLA Coding, Reimbursement & Market Access

AMA PLA descriptions and procedure narratives, coding strategy, payer policy review, reimbursement evidence planning and denial-risk analysis.

Typical deliverables: PLA descriptor of procedure (DOP) drafts; Coding / reimbursement strategy briefs; Payer evidence packages.

Explore service

Clinical Research, Data Analysis & Scientific Writing

Study protocols, clinical study report support, statistical interpretation, literature synthesis, manuscripts, abstracts and presentations.

Typical deliverables: Clinical evidence summaries; Study reports; Manuscripts; Abstracts; Data tables.

Explore service

Laboratory Operations & Quality Improvement

Laboratory startup, service-line implementation, workflow mapping, turnaround-time improvement, QC review, root-cause analysis and KPIs.

Typical deliverables: Operational assessments; Implementation plans; Workflow SOPs; Training and KPI dashboards.

Explore service

Precision Medicine & Advanced Diagnostics

Pharmacogenomics, oncology molecular testing, MRD workflows, infectious disease and AMR panels, with attention to limitations and reporting.

Typical deliverables: Test-menu strategy; Validation frameworks; Interpretation and reporting templates.

Explore service

Scientific Leadership & Project Advisory

Fractional scientific leadership, technical due diligence, vendor and technology assessments, program management and executive briefings.

Typical deliverables: Strategic roadmaps; Technical reviews; Milestone plans; Executive briefings.

Explore service

Not sure which service fits?

Tell us about your test, timeline and goals. We'll recommend the right scope during a consultation.

Schedule a Consultation Explore Services